36Kr's first | focus on the molecular diagnosis of thyroid tumors, and "Ruijing Bio" completed a new round of financing of nearly 100 million yuan

36Kr learned that Shanghai Ruijing Biotechnology Co., Ltd. (hereinafter referred to as "Ruijing Biotechnology") has completed a new round of financing of nearly 100 million yuan, which is led by Boyuan Capital, followed by Guotai Junan Innovation Investment, Yinshengtai Capital, and taking advantage of capital as financial advisor. This round of investment will be used for clinical pipeline advancement, scientific discovery and proof of concept of new products, and commercialization. Previously, Ruijing Bio also received Series A financing led by Yuanhe Origin, Zhen Fund and Jingxu Venture Capital.

Founded in 2017, Ruijing Bio launched a full-process series of products such as thyroid biopsy needles, multi-gene qPCR detection and NGS detection, Thyroscan thyroid nodule good and malignant classifier, and postoperative recurrence monitoring around thyroid cancer from preoperative sampling, diagnosis, and postoperative monitoring, providing a variety of solutions for the entire thyroid cancer diagnosis and treatment cycle.

It is reported that after more than four years of research and development and accumulation, the company's preoperative polygenic qPCR and NGS products have entered the clinical registration stage, and have been verified by tens of thousands of clinical samples; the company's exclusive product, the Thyroscan thyroid nodule good and malignant classifier, benchmarked against the United States Thyroseq, wants to replace cytopathological diagnosis.

According to reports, unlike the auxiliary diagnosis of registered PCR or NGS reagents, Thyroscan establishes a machine learning algorithm through multi-gene locus multi-module combination to achieve accurate diagnosis of the nature of preoperative thyroid nodules, risk stratification, prognosis judgment and guidance of postoperative thyroid cancer, so as to achieve accurate diagnosis and treatment. At present, the Thyroscan thyroid nodule good and malignant classifier is undergoing prospective clinical trials in China, while gradually accumulating a thyroid oncogene database of Chinese population. In addition, the company's launch of corresponding products for postoperative recurrence monitoring has also entered the clinical verification stage.

Courtesy of the enterprise

At present, the judgment of the benign and malignant nature of thyroid nodules mainly depends on traditional ultrasound imaging and cytopathological diagnosis, and nearly 30% of the clinical test results are unclear. In patients with uncertain benign or malignant nodules, there is a large degree of malignancy that is missed, the former is life-threatening, or benign nodules are missed, and the latter require exogenous thyroid hormones as an alternative therapy and regular monitoring of thyroid hormone levels. Thyroid hormone supplementation requires dynamic adjustment of oral hormone doses according to the patient's hormone target value, and taking too much or too little dose will bring potential health risks such as cardiovascular disease to patients, increasing the burden on patients and the medical system.

Although the overall prognosis of thyroid cancer is good, there is still a large gap compared with western developed countries, and some of the groups with extremely high malignant degrees have been shown in literature studies to have a strong correlation with specific molecular events. Thyroid cancer is graded by genetic testing and doctors are instructed in how to operate, so that a good prognosis of patients can be guaranteed to the greatest extent. In addition, thyroid nodules will also bring greater psychological burden to patients before the benign and malignant, so in order to achieve more accurate diagnosis and treatment of thyroid nodule patients, further improve the prognosis of thyroid cancer patients, reduce the psychological burden of patients, avoid the trauma caused by excessive treatment to patients and waste of medical resources, there is an urgent need to accurately judge the nature of thyroid nodules at the molecular level.

At the same time, Ruijing Bio is also working on the layout of postoperative chronic disease management of thyroid cancer to assist postoperative patients with health monitoring. The reason is that most thyroid cancer patients have a good prognosis, but postoperative patients still need years of health monitoring and medication. Many follow-up visits a year, from registration, payment, medical treatment, testing, medicine, etc., to wait in line many times, and the time for medical treatment is very short. This "long and short" not only wastes hospital resources, but also occupies a lot of valuable time for thyroid cancer patients themselves, and the experience is extremely poor; at the same time, the limited outpatient time of surgical experts cannot meet the needs of large postoperative patients.

In the future, the company will continue to lay out other cancers in accordance with this model, and gradually build a management database of cancer patients in China to accurately serve doctors and patients. According to reports, the company's business has covered more than a dozen provinces, nearly 100 top three hospitals, forming hundreds of customers.

At present, the population of thyroid nodules is large and growing rapidly, and the incidence of thyroid nodules in Chinese population is about 19-49%, of which 7-15% are diagnosed with thyroid cancer. The domestic thyroid cancer patient base is huge, the compound annual growth rate of new cases is as high as 22.86%, and the mortality rate of female thyroid cancer has also increased in recent years, and the overall trend is younger, and the situation is grim.

From the perspective of industry prospects, in the fifth edition of the WHO classification and grading standards for endocrine and neuroendocrine tumors just issued in 2022, it is clearly stated that the driving gene is the fundamental factor in the occurrence and development of papillary thyroid cancer, emphasizing the discovery of gene mutations such as BRAF, TERT, and RET fusion, which provides a basis for the guidance of advanced thyroid papillary carcinoma, cancer of high-grade thyroid follicular epithelial origin, adjuvant diagnosis of undifferentiated carcinoma patients, tumor biological behavior, prognosis judgment and efficient precision treatment.

At present, many hospitals can only use LDT to detect molecular markers of thyroid cancer, and there is an urgent need for commercial test kits for preoperative puncture samples. In 2020, there were 220,000 new cases of thyroid cancer in China, and it grew rapidly at a compound annual growth rate of 22.86%, in addition, the recurrence monitoring and health management after thyroid cancer surgery also has huge market potential, and the market capacity of the domestic thyroid cancer molecular detection track will reach nearly 10 billion yuan in the future.

In terms of team, founder Hong Hedong joined Boehringer Ingelheim Pharmaceutical Co., Ltd. in germany in his early years, from representative to supervisor to regional sales manager to achieve the first place in the region for many times; the company's CSO Dr. Yang Feng obtained a doctorate in molecular medicine from Peking University, and later worked as a project scientist at the University of California, San Diego School of Medicine, with rich experience in the field of basic research and technology transformation; the company's CTO Dr. Shi Han graduated from Tsinghua University with a bachelor's degree in chemical biology. He received his Ph.D. in life sciences from Northwestern University in the United States, and has many years of experience in R&D management of IVD enterprises in the United States, and has been responsible for the development of a variety of tumor NGS detection panel and PCR detection products.